AN OPEN-LABEL, PHASE I/II STUDY OF TWO DIFFERENT SCHEDULES OF DASATINIB (SPRYCEL) AND DECITABINE (DACOGEN) USED IN COMBINATION FOR PATIENTS WITH ACCELERATED OR BLASTIC PHASE CHRONIC MYELOGENOUS LEUKEMIA (Protocol CA180357)
The goal of this clinical research study is to learn if combining Spyrcel (dasatinib) and Dacogen (decitabine) can help to control CML. The dose level of decitabine will also be studied. Dasatinib is designed to block the protein that is responsible for chronic myeloid leukemia. Decitabine is designed to affect the mechanism that cells use to control the expression of certain genes, some of which are important in the progression of CML.
Treatment Location: N/A
Primary Objectives a) For phase I: To define the maximally tolerated dose (up to the target dose) of the combination of dasatinib (Sprycel) and decitabine (5-aza-deoxycitidine Dacogen) in patients with chronic myelogenous leukemia (CML) in the accelerated (AP) or blastic (BP) phases. b) For phase II: To assess the efficacy, measured as the response to therapy during the first 3 months of therapy, of the combination of dasatinib and decitabine in patients with CML in AP or blastic BP phases. Secondary Objectives a) To determine the duration of response and survival with the combination of dasatinib and decitabine in advanced phase CML. b) To establish the toxicity of the combination of dasatinib and decitabine therapy. c) To determine the effects on gene methylation of decitabine given in combination with dasatinib.
IRB Review and Approval Date: 06/12/2012
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Phase I/Phase II
For general questions about clinical trials: